Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-27 @ 12:33 PM
Study NCT ID:
NCT02256358
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tedy333@paik.ac.kr', 'phone': '82-51-797-0426', 'title': 'Kihwa Lee', 'organization': 'Haeundae Paik Hospital, Inje University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not include a placebo group.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Recording of complications at 5 minutes intervals during 30 minutes after operation', 'eventGroups': [{'id': 'EG000', 'title': 'Midazolam', 'description': 'Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.\n\nMidazolam: preoperatively injected intravenous 0.1 mg/kg midazolam', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketamine', 'description': 'Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.\n\nKetamine: Preoperatively injected intravenous 1mg/kg ketamine', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Emergence Agitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.\n\nMidazolam: preoperatively injected intravenous 0.1 mg/kg midazolam'}, {'id': 'OG001', 'title': 'Ketamine', 'description': 'Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.\n\nKetamine: Preoperatively injected intravenous 1mg/kg ketamine'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes', 'description': "The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam', 'description': 'Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.\n\nMidazolam: preoperatively injected intravenous 0.1 mg/kg midazolam'}, {'id': 'FG001', 'title': 'Ketamine', 'description': 'Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.\n\nKetamine: Preoperatively injected intravenous 1mg/kg ketamine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam', 'description': 'Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.\n\nMidazolam: preoperatively injected intravenous 0.1 mg/kg midazolam'}, {'id': 'BG001', 'title': 'Ketamine', 'description': 'Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.\n\nKetamine: Preoperatively injected intravenous 1mg/kg ketamine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'spread': '1.40', 'groupId': 'BG000'}, {'value': '4.21', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '4.18', 'spread': '1.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-10-01', 'resultsFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-06', 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence Agitation', 'timeFrame': 'During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes', 'description': "The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['child, ketamine, midazolam'], 'conditions': ['Psychomotor Agitation']}, 'descriptionModule': {'briefSummary': 'Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia', 'detailedDescription': "Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\\<2hr)\n\nExclusion Criteria:\n\n* children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT02256358', 'briefTitle': 'Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2012-127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'preoperatively injected intravenous 0.1 mg/kg midazolam', 'armGroupLabels': ['Midazolam']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketamine HCl'], 'description': 'Preoperatively injected intravenous 1mg/kg ketamine', 'armGroupLabels': ['Ketamine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kihwa Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Haeundae paik hospital, inje university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ki Hwa Lee', 'investigatorAffiliation': 'Inje University'}}}}